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    Summary
    EudraCT Number:2012-001125-27
    Sponsor's Protocol Code Number:CL3-78989-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-001125-27
    A.3Full title of the trial
    A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet?s Disease uveitis
    Estudio controlado frente a placebo, aleatorizado, doble enmascarado, de eficacia de Gevokizumab en el tratamiento de pacientes con Uveitis por enfermedad de Behçet
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis
    Eficacia de gevokizumab en el tratamiento de los pacientes con uveitis por enfermedad de Behçet
    A.4.1Sponsor's protocol code numberCL3-78989-002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratorios Servier S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratorios Servie S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S.L.
    B.5.2Functional name of contact pointLoreto TABOADA
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de los Madroños 33
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917489630178
    B.5.5Fax number0034913003249
    B.5.6E-mailloreto.taboada@es.netgrs.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/796
    D.3 Description of the IMP
    D.3.1Product nameGevokizumab
    D.3.2Product code S78989
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgevokizumab
    D.3.9.1CAS number 1129435-60-4
    D.3.9.2Current sponsor codeS78989
    D.3.9.3Other descriptive nameXOMA 052
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Behçet?s disease uveitis
    Uveitis por enfermedad de Behçet
    E.1.1.1Medical condition in easily understood language
    Behçet?s disease uveitis
    Uveitis por enfermedad de Behçet
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10071139
    E.1.2Term Behcet's uveitis
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet?s disease uveitis exacerbations
    El objetivo de este estudio es demostrar la superioridad de gevokizumab comparado con placebo añadido al la terapia estándar para reducir el riesgo de exacerbaciones de la uveitis por enfermedad de Behçet
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.
    Los objetivos secundarios son evaluar el efecto de gevokizumab en el resto de los criterios de eficacia y evaluar su seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Behçet?s disease diagnosis fulfilling the International Study Group Classification Criteria.
    - History of Behçet?s disease uveitis with ocular involvement of the posterior segment.
    - Patients with a stable backgroud treatment of oral corticosteroid and at least one immunosuppressive drug.
    - Male or female, age ?18 (or legal age of majority in the country) at selection
    - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
    - Diagnóstico de Enfermedad de Behçet cumpliendo los criterios de clasificación del grupo de estudioo Internacional.
    - Antecedentes de uveitis por enfermedad de Behçet con implicación del segmento posterior.
    - Pacientes con una terapia basal estable de corticosteroides orales y almenos un fármaco inmunosupresor .
    - Hombre o mujer, edad ? 18 (o mayoría de edad legal en el país en el momento de la selección
    - Para pacientes con potencial reproductivo, la voluntad de utilizar metodos anticonceptivos altamente efectivos.
    E.4Principal exclusion criteria
    - Infectious uveitis, uveitis due to causes other than Behçet?s disease.
    - Monocular vision
    - Presence of severe cataract or severe posterior capsular opacification.
    - Contraindication to mydriasis or presence of posterior synechiae.
    - Active TB disease.
    - History of severe allergic or anaphylactic reactions to monoclonal antibodies
    - History of malignancy within 5 years prior to Selection.
    - Infectious disease.
    - Known immunodeficiency.
    - Uveitis infecciosa, uveitis debida a otras causas distintas de la enfermedad de Behçet
    - Vision monocular
    - Presencia de catarata u opacificación capsular posterior grave
    - Contraindicación a la midriasis o presencia de sinequias posteriores
    - Enfermedad tuberculosis activa
    - Antecedentes de alergia grave o reacciones anafilácticas a los anticuerpos monoclonales
    - Antecedentes de malignidad, en los 5 años previos a la selección.
    - Enfermedad infecciosa
    - Inmunodeficiencia conocida
    E.5 End points
    E.5.1Primary end point(s)
    Time to first acute ocular exacerbation (number of days)
    Tiempo hasta la primera exacerbación ocular aguda ( número de días )
    E.5.1.1Timepoint(s) of evaluation of this end point
    From inclusion until the end of the core study
    Desde la inclusión hasta el final del estudio central
    E.5.2Secondary end point(s)
    - Ocular exacerbations
    - Visual acuity
    - Vitreous haze
    - Retinal infiltrates or acute retinal vasculitis
    - Anterior chamber
    - Safety measurements (adverse events, non ocular manifestations of Behçet's Disease, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...)
    - Exacerbaciones oculares
    - Agudeza visual
    - Bruma del vítreo
    - Infiltrados retinales o vasculitis retinal aguda
    - Cámara anterior
    - Medidas de seguridad ( acontecimientos adversos, manifestaciones no oculares de la enfermedad de behçet, signos vitales, radiografía de tórax, estándard ECG de 12 derivaciones, parámetros de laboratorio ...)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Ocular exacerbations : from inclusion to the end of the trial,
    -Vitreous haze, retinal infiltrates, acute retinal vasculitis, anterior chamber, visual acuity : at each visit of Part 1. Part 2 : at month 4 and end of trial,
    -Safety measurements : from selection to the end of the trial.
    - Exacerbaciones oculares: desde la inclusión hasta el final el estudio,
    - Bruma del vítreo, infiltrados retinales, vasculitis retinales agudas, cámara anterior, agudeza: en cada visita de la Parte 1. En la Parte 2 en el mes 4 y al final del estudio
    - Medidas de seguridad: desde la selección hasta el final del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Diseño de aparición de eventos ( estudio central ) + período en abierto ( parte 2 )
    Event driven design (core study) + open label (part2)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned60
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    China
    France
    Germany
    Greece
    Hong Kong
    India
    Italy
    Korea, Republic of
    Portugal
    Russian Federation
    Saudi Arabia
    Spain
    Tunisia
    Turkey
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as the Last Visit of the Last Participant as stated in the clinical protocol.
    El final del estudio se define como la Ultima Visita del último participante , tal y como se define en el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 110
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the study, as gevokizumab is not licensed, study drug will not be available. The subject will receive other treatment and/or have access to other appropriate care by his doctor.
    Después del final del estudio, teniendo en cuenta que gevokizumab no está comercializado, el fármaco del estudio no estará disponible. El sujeto recibirá otro tratamiento y/o tendrá acceso a unos cuidados apropiados por su médico
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-29
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